Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft vs. Fascia for Tympanoplasty

University of Missouri (MU)

Status: Withdrawn

Conditions: Tympanic Membrane Perforation

Treatments: Other: Fascia; Other: Skye Barrier

Study type: Interventional

Funder types: Other

Identifiers

NCT03028272

2006074

Details and patient eligibility

About

The trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and functional outcomes as fascia when used for tympanoplasties while offering benefits including reduced operative time, better patient satisfaction, and fewer complications.

Full description

A prospective randomized controlled trial will be conducted. Eligible patients will be identified, recruited and randomized to receive either repair using the standard fascia graft or repair using the Skye ActiveBarrier. Subjects will undergo a preoperative evaluation followed by TM repair and subsequent regular office visits to assess functional outcomes, complications, and satisfaction. Patients will be blinded to the substrate used for their repair. As there are two different approaches for a tympanoplasty (through the ear canal or incision behind the ear) based on the subject's ear anatomy and location of the perforation, a sham surgery will not be necessary to disguise which graft is received. At follow up visits, photos may be taken of patients' TMs and these photos will be evaluated for healing by an otologist who did not conduct the surgery in a blinded fashion. At the 1 year follow up appointment, subjects will be told which substrate they received and at the study's conclusion subjects will notified about the study's findings.

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Presence of a tympanic membrane perforation
2. Patient at PI's clinic

Exclusion criteria

1. Presence of cholesteatoma
2. Prior surgery on the same-sided TM or middle ear
3. Ossicular chain abnormalities
4. Congenital deformities involving the middle ear or eustachian tube
5. Refusal to undergo surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Fascia

Active Comparator group

Description:

Autologous donor substrate

Treatment:

Other: Fascia

Skye Barrier

Experimental group

Description:

Amniotic membrane allograft

Treatment:

Other: Skye Barrier